Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202003578252979 Date of Approval: 03/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Erector spinae plane block versus quadratus lumborum block in pediatric patients undergoing surgical repair of developmental dislocation (dysplasia) of the hip; a prospective randomized controlled trial
Official scientific title Erector spinae plane block versus quadratus lumborum block in pediatric patients undergoing surgical repair of developmental dislocation (dysplasia) of the hip; a prospective randomized controlled trial
Brief summary describing the background and objectives of the trial Regional anesthesia is an indispensable component of the practice of pediatric anesthesia. While neuraxial techniques have a robust history in pediatric anesthesia, peripheral regional anesthesia has more recently gained popularity particularly due to the escalation in the use of ultrasound guidance. 1-3 Erector spinae plane block (ESPB) is a novel regional anesthesia technique essentially described for providing thoracic analgesia when performed at the level of the T5 transverse process. Local anesthetic injected into the fascial plane deep to the erector spinae muscle spreads in a craniocaudal fashion over several dermatomal levels.[4] Quadratus lumborum block (QLB) is an effective regional anesthesia technique used in abdominal and hip surgeries for postoperative analgesia.[5] The aim of the current study is to compare the perioperative analgesic effects of ultrasound-guided erector spinae plane block versus quadratus lumborum block in pediatric patients undergoing surgical repair of developmental dislocation (dysplasia) of the hip (DDH).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,perioperative analgesia for DDH
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 22/06/2019
Actual trial start date
Anticipated date of last follow up 22/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
33041 Tanta University, Faculty of Medicine, Research Ethics Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control group all study time general anesthesia only 30 Placebo
Experimental Group ultrasound guided erector spinae plane block 0.3 ml/kg of bupivacaine 0.25%. The total dose of bupivacaine would not exceed2 mg/kg. single shot Ultrasound-guided unilateral Erector Spinae Plane Block after induction of general anesthesia 30
Experimental Group ultrasound guided quadratus lumborum 0.3 ml/kg of bupivacaine 0.25%. The total dose of bupivacaine would not exceed 2 mg/kg. single shot ultrasound guided unilateral quadratus lumborum block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 1- 6 years either gender ASA I-II undergoing unilateral elective surgical repair of DDH parental refusal allergy to the study drug any contraindication to regional anesthesia e.g. infection at injection site or coagulopathy. Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Year(s) 6 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2019 Tanta University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Algeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome CHEOPS scale during the first 12 h postoperative immediately after transfer to PACU, at 1h, 2h, 4h, 6h, 8h, 12h postoperative
Secondary Outcome total intraoperative fentanyl consumption once after the end of surgery
Secondary Outcome total postoperative rescue analgesic consumption once after 24 h postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Algeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Faculty of Medicine Algeish street Tanta Egypt University
Secondary Sponsor Department of anesthesia and surgical ICU Algeish street Tanta Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohye Eldin 55 Stad street Tanta Egypt
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and surgical ICU Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and surgical ICU Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin mohd_yazed75@yahoo.com 01099707168 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of anesthesia and surgical ICU Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data of the primary outcome Informed Consent Form data will be available for 6 months after the manuscript is accepted for publication. data can be accessed through the corresponding author within the specified time frame.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information